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1 Department of Pharmacy Practice, National College of Pharmacy, Kozhikode, 673602 (Kerala) 2 Assistant Professor, Department of Pharmacy Practice, National College of Pharmacy, Kozhikode 3 Associate Professor, Department of Neurology, KMCT Medical College Hospital, Kozhikode, 673602 (Kerala) *Corresponding Author Muhammed Yaseen Department of Pharmacy Practice, National College of Pharmacy, Kozhikode, 673602 (Kerala), India Abstract Background: The present study was done to determine the impact of gut microbiome in altering the symptoms of fibromyalgia.. Aim: To study the benefits of adding probiotics along with standard therapy in fibromyalgia. Materials and Methods: A total of 104 patients aged 20-65 were included in this study. The patients were divided into two groups, Case (N=52) and Control (N=52). The Case group received Bacillus subtilis probiotic (10 billion CFU’s) along with Amitriptyline (10mg), whereas the Control group received Amitriptyline alone (10mg). The patients were evaluated 14 days after baseline, and then monthly for six months. Assessment of patients was done with the help of the Visual Analog Scale (VAS) and the Revised Fibromyalgia Impact Questionnaire (FIQR). Results: Significant improvement was observed in both groups after ten weeks of treatment (p<0.05). Percentage reduction in VAS –Pain score, FIQR-Pain score, and the FIQRTotal score was slightly higher in the case group compared to that of control (difference of approximately 2%). However, the percentage reduction in the FIQR-Sleep quality score showed a greater improvement in the Case group to that of control (difference of approximately 23%). Conclusion: Both groups showed significant improvement in pain, functional status and neuropsychological symptoms; however, the addition of probiotics as an adjuvant to standard therapy showed additional improvement in pain, functional status, and sleep quality. Consequently, based on results obtained, probiotics can be used as an adjuvant in the management of Fibromyalgia.

A Comparative Study in Patients with Fibromyalgia Receiving Probiotics Along with Standard Therapy